临床试验中的利益冲突与防范策略  

Interest Conflicts and Prevention Strategy for Clinical Trial

作　　者：李晓[1] 于萍[1] 王希利[1] 吕晓东[1] 

机构地区：[1]辽宁中医药大学附属医院伦理办公室,辽宁沈阳110032

出　　处：《中国医学伦理学》2015年第1期44-46,共3页Chinese Medical Ethics

基　　金：重点病种中西医结合复杂干扰有效要素筛选和优化方案研究(JDZX2012101)

摘　　要：医院临床研究中,研究者及伦理委员会成员的个人经济利益与职责之间的冲突会对试验研究和受试者产生损害,可能会使临床试验结果的真实性和客观性遭到质疑,损害受试者的权益,损害医院的公信力。为了防范冲突的发生,提出处理临床试验中利益冲突的策略:加强立法建设、完善处理办法,成立利益冲突委员会,坚持公开原则,对有关人员进行审查与限制,定期组织研究者和伦理委员参加培训。In medical clinical study, the researchers and the ethics committee members＇ personal economic in-terests and responsibilities conflicts may produce damage to experimental research and the subjects, may make the study being questioned the authenticity and the objectivity of clinical trial results, also damage to the subjects＇ rights and interests and damage the credibility of hospital. In order to prevent the happening of the conflict, put forward the strategies：strengthen legislation construction, improve the treatment method, set up a conflict of interest com-mittee, adhere to the principle of open, review and restriction to the personnel, regularly organize researchers and ethics committee members attend the training.

关 键 词：临床试验 利益冲突 伦理委员会 伦理审查 

分 类 号：R197.32[医药卫生—卫生事业管理]